Axial lengthening thrombus capture system

ABSTRACT

Disclosed herein are systems and methods to remove material of interest, including blood clots, from a body region, including but not limited to the circulatory system for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT), cerebrovascular embolism, and other vascular occlusions.

PRIORITY CLAIM

This application claims the benefit under 35 U.S.C. §119(e) as anonprovisional application of each of U.S. Provisional App. No.62/202,074 filed on Aug. 6, 2015, 62/273,418 filed on Dec. 30, 2015, and62/345,863 filed on Jun. 6, 2016, each of which is incorporated byreference in their entireties.

BACKGROUND

Field of the Invention

The invention relates to, in some aspects, systems and methods to removematerials of interest, including blood clots, from a body region,including but not limited to the circulatory system for the treatment ofpulmonary embolism (PE), deep vein thrombosis (DVT), cerebrovascularembolism, and other vascular occlusions.

Description of the Related Art

It is understood that undesirable materials such as blood clots (whichcould be referred to as thrombi, thromboemboli, or emboli herein) in theblood vessels may partially or completely occlude blood vessels in areasof the coronary, cerebrovascular, pulmonary, peripheral venous, andperipheral arterial circulation resulting in myocardial infarction,stroke, pulmonary embolism, deep vein thrombosis, and infarction of anextremity respectively.

Various therapies and devices are known to either dissolve, debulkand/or aspirate the thromboemboli. For instance, anticoagulant agentssuch as heparin and warfarin help stabilize blood clots and preventfurther forming of clots while thrombolytic agents such as urokinase,streptokinase, and tPA assist in dissolving blood clots. These agentscan be delivered via systemic infusion or catheter-based infusion to theintended location. While thrombolytic agents can be effective indissolving blood clots, they require a long time duration in order forthe agents to dissolve the blood clots; thus patients may need to remainin the hospital intensive care unit (ICU) during thrombolytic infusion.Relatively long lengths of stay can increase healthcare costssignificantly. A major limitation for these thrombolytic agents is thatthey can potentially cause intracranial, gastrointestinal,retroperitoneal, and pericardial bleeding, among other sites, which canbe often life-threatening and cause significant morbidity and mortalityrisks.

Mechanical debulking and/or aspiration devices can be used to remove theobstruction. These mechanical techniques can either macerate, aspirate,or a combination thereof in order to remove the blood clots. Anadvantage of mechanical therapy is that it can remove thrombus directlyfrom the blockage area and immediately eliminates the obstruction andmay be superior to thrombolytic agents in some cases. However, currentmechanical therapies have some major limitations. There is minimal to noflow during the procedure thus there is little time before patients maybecome hemodynamically instable. The debris removed from mechanicaltreatment can travel distally creating additional embolization. Thesmall size devices are unable to remove large amount of blood clots inshort time periods thus patients may become hemodynamically instable.

Catheter-based removal of blood clots from larger blood vessels (e.g.,pulmonary arteries) have had limited success compared to smaller bloodvessels (e.g., coronary arteries). Catheter pulmonary embolectomy iswhere pulmonary emboli are removed percutaneously using severaltechniques. Fragmentation thrombectomy breaks blood clots into smallerpieces, most of which travel further downstream, resulting in distalembolization. It is sometimes used in combination with thrombolytics.With the rheolytic thrombectomy, high velocity saline jets create aVenturi effect and draw the fragments of the clot into the catheter.This method poses risk of hemolysis. Finally the aspiration techniquesdraw the clot into a catheter via suction. All of these techniques relyon the catheter used to remove the clots from blood vessels. The usersuse small catheters to remove or break up large amounts of blood clot.This procedure is therefore time-consuming and inefficient. Once theblood clots are broken into small pieces, the debris can migratedistally and create unwanted emboli. Rheolytic therapy poses the risk ofhemolysis. Additionally, the ability to suction is limited due the smallcatheter size suctioning large emboli. These limitations causeunnecessary duress to the user and risk to the patient.

Catheter-based removal of blood clots in general also has a majorlimitation when distal working space within a body lumen is limited.Conventional devices may require full axial and/or radial deployment andexpansion to be functional, and as such flexibility to use such devicesfor a variety of clinical situations involving differing clot or othermaterial sizes to be removed can be very limited. Therefore, conditionswhere there is limited distal space of blood vessels can render theseconventional devices ineffective.

It is evident that all of the therapeutic options available to patientswith blood clots or other undesirable material in blood vessels andother body lumens have limitations. Anticoagulation only limitspropagation of clots but does not actively remove it. Thrombolytictherapy poses a risk of major bleeding. Catheter embolectomy is noteffective to manage removal of material in large vessels. Additionally,these devices require distal space to fully deploy to be functional thusineffective in tight distal spaces. Surgical embolectomy can be highlyeffective but highly invasive, and has a high rate of morbidity andmortality. There is a need for a direct mechanical treatment that is asor more effective as surgical embolectomy removing large blood clots butcan be performed using endovascular techniques and restore immediateblood flow, and cause a lower incidence of complications.

SUMMARY

In some embodiments, disclosed herein is a capture system for selectedmaterials within a body. The capture system can include a captureassembly configured to isolate unwanted material, e.g., a blood clotthat can include a shape memory body such as made of, for example, amesh material and having a distal end connected to a capture guidehaving a distal opening. The shape memory body can further include aproximal end connected to a first shaft, and a tubular sidewall betweenthe proximal end and the distal end. The capture assembly can beconfigured to expand the capture guide and the distal opening end whenthe shape memory body proximal end is compressed in the delivery system.The shape memory body can be movable from a first configuration having afirst axial length and a second configuration having a second axiallength. The shape memory body can be configured to roll out, invert,evert, and/or variably lengthen proximally or distally from the firstconfiguration to the second configuration. The second axial length canbe different from the first axial length. The width of the captureassembly can, in some cases not substantially change from the firstconfiguration to the second configuration. The capture system can alsoinclude a control line configured to independently move the captureassembly from the first configuration to the second configuration. Thefirst shaft can extend within the longitudinal axis of the captureassembly.

In some embodiments, disclosed herein is a material, e.g., a clotcapture system. The system can include a first, outer tubular shaftcomprising a central lumen, the first outer tubular shaft comprising aproximal portion and a distal portion, the distal portion more radiallyexpandable than the proximal portion. The system can also include asecond tubular shaft configured to be positioned within the centrallumen of the first shaft. The system can also include a third tubularshaft configured to be positioned within a central lumen of the secondshaft. The shape memory tubular body can include a first end, a secondend, and an axial length therebetween, the first end having aproximal-facing opening and a ring-shaped capture guide attached to acircumference of the proximal-facing opening, the capture guide operablyattached to the second tubular shaft, the second end attached to anouter wall of the third tubular shaft. The shape memory tubular body canbe compressed within the central lumen of the second tubular shaft in afirst delivery configuration. The shape memory tubular body can betransformable to a second configuration in which the first end and thecapture guide is radially expanded up to a dynamic fold point, but thesecond end and a segment of the shape memory tubular body extends in adifferent direction, such as proximally past the dynamic fold point, andremains radially compressed within the central lumen of the secondtubular shaft and the second end is positioned proximal to the first endand the shape memory tubular mesh body has a first expanded axiallength. The shape memory tubular body can be transformable to a thirdconfiguration in which the shape memory tubular body has a secondexpanded axial length greater than the first expanded axial length, anda width of the shape memory tubular shaft along its second expandedaxial length is the same or substantially the same as a width of theshape memory tubular shaft along its first expanded axial length. Thefirst tubular shaft can be configured to be reversibly coupled withrespect to the second tubular shaft in the delivery configuration andaxially movable with respect to the third tubular shaft in the secondconfiguration. In some embodiments, the second expanded axial length isabout or at least about, for example, 105%, 110%, 115%, 120%, 125%,130%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, or more of thefirst axial length. The capture system of claim 1, wherein the shapememory body can be porous, semi-permeable, and non-porous, and includenitinol braided, woven, or non-woven mesh, or nitinol wire. In someembodiments, the tubular body is coated with a hydrophilic orhydrophobic agent, or noncoated, and may not include a shape memorymetal or material. In some embodiments, the tubular mesh body isconfigured to invert, evert, or roll out with respect to the first,second, and/or third shaft. The system can also include a control lineextending proximally from the capture guide, either terminating on asleeve on one of the shafts or extending proximally to the proximal endof the system. In some embodiments, the system includes a suctionelement configured to operably connect with the proximal opening of theshape memory tubular body. The system can also include a mechanicalthrombectomy element, such as a macerator. The system can also include afilter collection chamber configured to collect and filter bloodobtained from the suction element. The system can further include an

expanding guide catheter configured to receive the capture assembly inthe form of a kit. The expanding guide element can include an openfunnel distal tip, that can be porous in some embodiments to allow flowaround the funnel distal tip.

In some embodiments, disclosed herein is a material, such as a clotcapture system that can include a first, outer tubular shaft comprisinga central lumen; a second tubular shaft configured to be positionedwithin the central lumen of the first shaft, the second tubular shaftcomprising a proximal portion and a distal portion, the distal portionmore radially expandable than the proximal portion; a third tubularshaft configured to be positioned within a central lumen of the secondshaft; a tubular mesh comprising a first end, a second end, and an axiallength therebetween, the first end having a proximal-facing opening anda ring-shaped capture guide attached to a circumference of theproximal-facing opening, the capture guide operably attached to thesecond tubular shaft, the second end attached to an outer wall of thethird tubular shaft. The tubular mesh can be compressed within thecentral lumen of the second tubular shaft in a delivery configuration.The tubular mesh can also be transformable to a second configuration inwhich the first end and the capture guide is radially expanded but thesecond end and a portion, such as a minority, half, or a majority of thetubular mesh remains radially compressed within the central lumen of thesecond tubular shaft and the second end is positioned proximal to thefirst end and the tubular mesh has a first expanded axial length. Thetubular mesh can be transformable to a third configuration in which thetubular mesh has a second expanded axial length greater than the firstexpanded axial length, wherein a width of the tubular mesh along itssecond expanded axial length is substantially the same as a width of thetubular mesh along its first expanded axial length, wherein the thirdtubular shaft extends distally through the proximal end opening as wellas the second axial expanded length of the shape memory tubular body. Insome embodiments, the tubular mesh is not under tension or substantiallyunder tension in the second configuration or the third configurationdefining an axial working range of the tubular mesh.

In some embodiments, a material, such as a clot capture system includesa first, outer tubular shaft comprising a central lumen; a secondtubular shaft configured to be positioned within the central lumen ofthe first shaft, the second tubular shaft comprising a proximal portionand a distal portion, the distal portion more radially expandable thanthe proximal portion; a third tubular shaft configured to be positionedwithin a central lumen of the second shaft; a tubular body that mayinclude shape memory materials that includes a first end, a second end,and an axial length therebetween, the first end having a proximal-facingopening and a ring-shaped capture guide attached to a circumference ofthe proximal-facing opening, the capture guide operably attached to thesecond tubular shaft via a sleeve circumscribing a portion of the secondtubular shaft, the second end attached to an outer wall of the thirdtubular shaft. The shape memory tubular body can be compressed withinthe central lumen of the second tubular shaft in a deliveryconfiguration. The shape memory tubular body can be transformable to asecond configuration by axial movement of the second tubular shaft withrespect to the first tubular shaft, in which the first end and thecapture guide is radially expanded but the second end and a segment ofthe shape memory tubular body remains radially compressed within thecentral lumen of the second tubular shaft and the second end ispositioned proximal to the first end and the shape memory tubular meshbody has a first expanded axial length. The shape memory tubular bodycan be transformable to a third configuration by movement of the secondtubular shaft with respect to the third tubular shaft, in which theshape memory tubular body has a second expanded axial length greaterthan the first expanded axial length, wherein a width of the shapememory tubular shaft along its second expanded axial length issubstantially the same as a width of the shape memory tubular shaftalong its first expanded axial length, wherein the third tubular shaftextends distally through the proximal end opening as well as the secondaxial expanded length of the shape memory tubular body. The shape memorytubular body can, in some cases, be transformable to a fourthconfiguration by movement of the second tubular shaft with respect tothe third tubular shaft. The shape memory tubular body can have a thirdexpanded axial length greater than the second expanded axial length,wherein a width of the shape memory tubular shaft along its thirdexpanded axial length is less than the width of the shape memory tubularshaft along its second expanded axial length. The clot capture systemcan also include a sleeve that includes a metal or polymer, and thesleeve can be partially or fully radiopaque or radiolucent underfluoroscopy or other imaging.

Also disclosed herein is a method of performing a thrombectomy. Themethod can include, for example, accessing the interior of a bloodvessel; advancing a thrombus capture device comprising a captureassembly through the blood vessel; positioning the thrombus capturedevice such that a distal end of the device is distal to the thrombus;actuating the capture assembly to isolate the thrombus within thecapture device, wherein the capture assembly is movable from a firstconfiguration having a first axial length and a second configurationhaving a second axial length, the second axial length being differentfrom the first axial length, wherein the width of the capture assemblydoes not substantially change from the first configuration to the secondconfiguration; and suctioning, macerating, and/or mechanically removingthe thrombus.

In some embodiments, a method of performing a thrombectomy can include,for example, accessing the interior of a blood vessel; advancing anexpanding guiding catheter through the blood vessel; positioning theexpanding guiding catheter such that a distal end of the device isproximal to a thrombus; retracting the expanding guide catheter outermember to expand a funnel tip and exposing an expandable inner member;advancing a thrombus capture device comprising a capture assemblythrough the expanding guide catheter; positioning the thrombus capturedevice such that a distal end of the device is distal to or within thethrombus; and actuating the capture assembly to isolate the thrombuswithin the capture device. The capture assembly can be movable from afirst configuration having a first axial length and a secondconfiguration having a second axial length, the second axial lengthbeing different from the first axial length. The width of the captureassembly may not substantially change from the first configuration tothe second configuration. The method can also include retracting thecapture assembly with the thrombus into an expanding guide catheterfunnel tip and expandable inner body. The method can also includeaxially lengthening the thrombus capture device distally and retractingthe thrombus into the funnel tip of the expanding guide catheter. Themethod can further include radially shortening the thrombus capturedevice to compress the thrombus and promote removal of the thrombus.

In some embodiments, disclosed herein is a clot capture system that caninclude a capture assembly configured to isolate a blood clot. Thesystem can include a shape memory body that has a distal end connectedto a capture guide comprising a distal or proximal opening. The shapememory body can also include a proximal end connected to a first shaft,and a sidewall between the proximal end and the distal end. The captureguide and the distal zone of the shape memory body opening end can alsobe fully or partially recaptured inside the outer sheath. The captureassembly can be configured to radially expand the capture guide and adistal zone of the shape memory body opening end while the shape memorybody proximal end remains compressed in the delivery configuration. Thecapture assembly can be movable from a first configuration having afirst axial length to a second configuration having a second axiallength. The shape memory body can be configured to roll out, invert,evert, and/or variably lengthen proximally from the first configurationto the second configuration. The second axial length can be differentfrom the first axial length. The width of the capture assembly can insome cases not substantially change from the first configuration to thesecond configuration.

Also disclosed herein is a capture assembly configured to isolate ablood clot including a shape memory body including a proximal end and adistal end connected to a capture guide including a distal opening, aproximal end connected to a shaft, and a sidewall between the proximalend and the distal end. The capture assembly can be configured to expandthe capture guide and the distal shape memory body opening end while theshape memory body proximal end is compressed in the deliveryconfiguration between a first shaft and a second shaft, and movable froma first configuration having a first axial length and a secondconfiguration having a second axial length. The shape memory body can beconfigured to roll out/unroll, invert, evert, and/or variably lengthenproximally from the first configuration to the second configuration. Thesecond axial length can be different from the first axial length. Insome cases, the width of the capture assembly does not substantiallychange from the first configuration to the second configuration.Furthermore, the shape memory body can be fully or partially recapturedinside the outer sheath once deployed. The system can also include asleeve coupled a control line connected to the second shaft configuredto move the capture assembly from the first configuration to the secondconfiguration. The first shaft and the second shaft can be off-axis withrespect to the capture assembly.

Also disclosed herein is a method of performing a thrombectomy. Themethod can include any number of the following: accessing the interiorof a blood vessel; advancing a thrombus capture device comprising acapture assembly through the blood vessel; positioning the thrombuscapture device such that a distal end of the device is distal to thethrombus; actuating the capture assembly to isolate the thrombus withinthe capture device, wherein the capture assembly is movable from a firstconfiguration having a first axial length and a second configurationhaving a second axial length, the second axial length being differentfrom the first axial length, wherein the width of the capture assemblydoes not substantially change from the first configuration to the secondconfiguration; and suctioning the thrombus.

In some embodiments, the methods can include any number of thefollowing: accessing the interior of a blood vessel; advancing anexpanding guiding catheter through the blood vessel; positioning theexpanding guiding catheter such that a distal end of the device isproximal to a thrombus; retracting the expanding guide catheter outermember to expand a funnel tip and exposing an expandable inner member;advancing a thrombus capture device comprising a capture assemblythrough the expanding guide catheter; positioning the thrombus capturedevice such that a distal end of the device is distal to or within thethrombus; actuating the capture assembly to isolate the thrombus withinthe capture device, wherein the capture assembly is movable from a firstconfiguration having a first axial length and a second configurationhaving a second axial length, the second axial length being differentfrom the first axial length wherein the width of the capture assemblydoes not substantially change from the first configuration to the secondconfiguration; and retracting the thrombus into an expanding guidecatheter funnel tip and expandable inner body. In some embodiments, thecapture guide is first recaptured into the outer sheath of the deliverycatheter and then retract into the expanding guide catheter funnel tipand expandable inner body.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates examples of a catheter system, and various possibleelements that can be included in a material capture system, according tosome embodiments of the invention.

FIG. 2 illustrates a close-up view of the thrombus capture systems ofFIGS. 1 and 2.

FIG. 3 illustrates an axially-lengthening thrombus capture (ALTC) systemin the initial deployment configuration with the ALTC device expanded,according to some embodiments of the invention.

FIG. 4 illustrates a close up view of the ALTC system distal segmentposition in the delivery configuration indicating the outer sheath andnose tip, according to some embodiments of the invention.

FIG. 5 illustrates the distal end of an axial lengthening thrombuscapture device at the initial deployment position, according to someembodiments of the invention.

FIG. 6 illustrates the axial lengthen thrombus capture device retractingproximally to deploy and lengthen, according to some embodiments of theinvention.

FIG. 7 illustrates the axial lengthen thrombus capture device is fullydeployed and the funnel tip of the guide catheter is positioned withinthe ALTC device, according to some embodiments of the invention.

FIGS. 8 and 9 illustrate different views of the initial deploymentposition of the ALTC Device and the funnel tip of the suction catheter,according to some embodiments of the invention.

FIG. 10 illustrates the partially deployed ALTC Device, according tosome embodiments of the invention.

FIG. 11 illustrates an ALTC device deployed configuration where thefunnel tip of the suction catheter is positioned inside the ALTC device,according to some embodiments of the invention.

FIG. 12 illustrates the Axial Lengthening Thrombus Capture (ALTC)assembly wherein the distal end of the ALTC device is in the expanded(deployed) configuration and is fixed to the thrombus capture guide andcapture pullwire, according to some embodiments of the invention. Forpurpose of illustration, the proximal end is in a collapsedconfiguration and extends proximally.

FIG. 13 illustrates the axial lengthening thrombus capture device in theinitial deployed configuration, according to some embodiments of theinvention.

FIG. 14 illustrates the thrombus capture element of the ALTC device thatcan include a stent or braided mesh, according to some embodiments ofthe invention.

FIGS. 15A-C illustrate an embodiment of the ALTC system, a distalportion of the ALTC System and a proximal portion of the ALTC Systemrespectively.

FIG. 16A illustrates another embodiment of the axial lengtheningthrombus capture device in the delivery configuration, according to someembodiments of the invention.

FIG. 16B illustrates the axial lengthening thrombus capture device inthe initial deployed configuration wherein the outer sheath is retractedto expanded the axial lengthen thrombus capture device. The loop iscoupled to the sleeve wherein it is coupled to the capture cathetershaft, according to some embodiments of the invention.

FIG. 16C illustrates the axial lengthening thrombus capture deviceretracting proximally and lengthening, according to some embodiments ofthe invention.

FIG. 16D illustrates the lengthening of the axial lengthening thrombuscapture device and in some cases at full deployment, according to someembodiments of the invention.

FIGS. 17A-D illustrate different configurations of the ALTC device,according to some embodiments of the invention.

FIGS. 18A-B illustrate an embodiment of a distal portion of theaxially-lengthening thrombus capture system with a cover elementradially outward of, and partially or completely circumscribing thecapture guide of the ALTC device, which can be in the shape of a ring asillustrated.

FIGS. 19A-C illustrates an embodiment of an axially-lengthening thrombuscapture system, configured to allow the guidewire to distally exit thesystem prior to exiting the luer port at the proximal end of the system.

FIG. 20A illustrates the expanding guide catheter system in the deliveryconfiguration, according to some embodiments of the invention.

FIG. 20B illustrates the expanding guide catheter system wherein thefunnel tip is in deployed position and the obturator is positioned inthe expanding guide catheter lumen, according to some embodiments of theinvention.

FIG. 20C illustrates the expanding guide catheter having a funnel tip,expanding distal segment and non-expanding proximal segment, accordingto some embodiments of the invention.

FIG. 20D illustrates an obturator, according to some embodiments of theinvention.

FIGS. 21A-C illustrate the expanding guide catheter system including theexpanding guide catheter, outer cover and obturator, according to someembodiments of the invention.

FIG. 21D illustrates an embodiment wherein a cover tip encapsulates thedistal end of the outer cover of the expanding guide catheter system,according to some embodiments of the invention.

FIG. 22 illustrates the outer sheath assembly of the capture device,according to some embodiments of the invention.

FIGS. 23 and 24 illustrate the distal end and proximal end of the outersheath assembly respectively.

FIG. 25 illustrates the capture catheter assembly, according to someembodiments of the invention.

FIG. 26 illustrates the proximal end of the capture catheter, accordingto some embodiments of the invention.

FIG. 27 illustrates an embodiment of a key cap feature to enable ananti-rotation of the hypotube pusher.

FIGS. 28 and 29 illustrates the suction catheter that can include afunnel tip, catheter shaft, and connector with seal, according to someembodiments of the invention.

FIG. 30 illustrates the distal end of the suction catheter indicatingthe funnel tip and catheter shaft, according to some embodiments of theinvention.

FIG. 31 illustrates the proximal end of the suction catheter indicatingthe connector with seal and ports for use with filter chamber and accessto flush catheter lumen, according to some embodiments of the invention.

FIGS. 32-41 illustrate different macerator designs and shapes, accordingto some embodiments of the invention.

FIG. 42 illustrates a filter collection chamber that can include aninflow port to connect to a syringe, an outflow port to connect to thesuction catheter, a plunger, a filter to filter blood clot or debris andretain in the chamber and a chamber to collect blood clot or debris,according to some embodiments of the invention.

FIG. 43 illustrates a blood clot lodging in the left side of pulmonarysystem, according to some embodiments of the invention.

FIGS. 44A and 44B illustrate blood clots residing in the left sidepulmonary system and the capture device respectively, according to someembodiments of the invention.

FIG. 45 illustrates the initial deployment configuration of the axiallengthening thrombus capture device positioned distal to the thrombusoccluded area and a funnel tip positioned proximal to the thrombusocclusion, according to some embodiments of the invention.

FIG. 46 illustrates the axial lengthening thrombus capture devicelengthening proximally to capture the thrombus, according to someembodiments of the invention.

FIG. 47 illustrates the axial lengthening thrombus capture devicecompletely capturing the thrombus, and a funnel tip is inside the axiallengthening thrombus capture device.

FIG. 48A illustrates the delivery configuration of the capture catheterdevice, according to some embodiments of the invention.

FIG. 48B illustrates the initial deployment position of the axiallengthening thrombus capture device, according to some embodiments ofthe invention.

FIG. 48C illustrates the lengthening of the axial lengthening thrombuscapture device, according to some embodiments of the invention.

FIG. 48D illustrate the final deployment of the axial lengtheningthrombus capture device, according to some embodiments of the invention.

FIGS. 49A and 49B illustrate another embodiment of the axial lengtheningthrombus capture device wherein the guidewire lumen and capture catheteris offset to the longitudinal axis of the axial lengthening thrombuscapture device, according to some embodiments of the invention.

FIG. 50A-50G illustrate an embodiment of the retrieval of thrombus intothe expanding guide catheter wherein the ALTC device lengthens distallyand creates additional space and the thrombus is redistributed andenable better retrieval into the expanding guide catheter. The funneltip and expanding section of the expanding guide catheter alsofacilitate the ease of thrombus retrieval.

DETAILED DESCRIPTION

The present invention provides, in some embodiments, systems and methodsthat can be delivered percutaneously in a body to retrieve and removalmaterials including blood clots, stones/calculi, and/or foreignmaterials in a body lumen, including a blood vessel, such as an arterialvessel or a venous vessel within the circulatory system. The presentinvention can, in some embodiments, also apply to nonvascular areas totreat, for example, gallstones, kidney stones, common bile duct stones,and the like.

Systems can be delivered percutaneously, via a cut-down approach, athoracoscopic approach, or via other approaches, for example, using acatheter system 35, of which a perspective view of an embodiment isshown in FIG. 1. FIG. 1 also illustrates examples of various possibleelements that can be included in a material capture system, according tosome embodiments of the invention. As illustrated in FIG. 1, included insome embodiments are any number of, such as one, two, or more of thefollowing components: a first tubular member, such as an outer sheath 1,a second tubular member, such as a capture catheter 12, a third tubularmember, such as a guidewire tube 6 an axial lengthening thrombus capturedevice 8, a suction catheter 2, and a filter collection chamber 5. Theouter sheath 1 can, in some embodiments, be an elongate tubular memberwith a central lumen therethrough, and have a proximal end 1000 and adistal end 1001. The distal end 1001 of the outer sheath 1 can beoperably connected to a capture device (e.g., tubular mesh 8), which canbe movably axially with respect to the outer sheath 1. In someembodiments, the outer sheath 1 has a relatively rigid proximal portionand a distal portion that is more flexible than the relatively rigidproximal portion, which can be advantageous to flexibly expand ifnecessary to accommodate the passage of large clots and/or othermaterials. The proximal end 1000 of the outer sheath 1 can connect to aproximal hub 1003 that may include any number of: the suction catheter2, capture catheter 12, guidewire tube 6, and filter collection chamber5. Non-limiting examples of other optional elements that can be includedin the system (not shown in FIG. 1) include a macerator tool (describedelsewhere herein) and a discrete expanding guide catheter (describedelsewhere herein. In some embodiments, the outer sheath 1 has a lumenconfigured to house the suction catheter 2, which in turn has a lumenconfigured to house the capture catheter 4, which in turn has a lumenconfigured to house the guidewire tube/guidewire lumen assembly 6 andthe axial lengthening thrombus capture device (ALTC device) 8, which inturn has a lumen configured to house a guidewire (not shown)therethrough. An ALTC device as defined herein can include anystructure, such as a net-like structure for example, configured tocapture materials within a body location and axially lengthen andshorten through a working range, with or without radially shortening inwidth or diameter throughout that working range depending on the desiredclinical result. In some embodiments, the outer sheath 1 has an innerdiameter configured to house the capture catheter 12 coaxially therein,and the capture catheter 12, which in turn has a lumen configured tohouse the guidewire tube 6 and the body of the ALTC device 8. The ALTCdevice 8 can in some embodiments including a mesh net-like structurewith a proximal-facing opening at one end that can be made of a shapememory metal or polymer, a non-shape memory metal such as stainlesssteel, or another non-shape memory fabric, embodiments of which aredescribed in detail elsewhere herein. In some embodiments, conventionalnet-like structures such as used in IVC and other embolic filters can beutilized with systems and methods herein. In some embodiments, athrombus capture device can be configured in some embodiments to axiallylengthen throughout a working range, with or without radially shorteningthe device throughout the working range.

FIG. 2 illustrates a close-up view of the proximal end 1000 of thethrombus capture systems of FIG. 1. Illustrated is outer sheath 1configured to, in some embodiments, house suction catheter 2therethrough. Also illustrated is the proximal end of the outer sheath 1which can terminate in a connector 17 and hemostasis seal 190, of whichanother tube, such as the suction catheter 2 (and/or capture catheter 4)can be inserted coaxially into. The proximal end of the suction catheter2 can also include a connector 3 having a seal, and a lumen of which thecapture catheter 12 can be inserted into. The capture catheter 4 canalso include a connector with a seal 18 at its proximal end. Theguidewire tube 6 with a lumen to house a guidewire therethrough can beconfigured to fit coaxially within the capture catheter shaft 12. Alsoillustrated is an optional filter collection chamber 5 with a lumenfluidly connected to a lumen of the suction catheter 2. A proximal hub17 is also illustrated, as well as a flush port 20. In some embodiments,suction is not required (and as such a suction catheter 2 is notincluded in the system), and the clot or other materials can be capturedeither mechanically, hydraulically and/or maceration via the ALTC device8.

FIG. 3 illustrates an axially-lengthening thrombus capture system 35 inthe initial deployment configuration with the ALTC device 8 radiallyexpanded, according to some embodiments of the invention. Alsoillustrated is nose tip 7 distal to the ALTC device 8. Relative axialmovement of the outer tube 1 with respect to capture catheter 4 canallow for transformation of a first end (e.g., an expanded proximal endwith a proximal-facing opening, or distal or laterally facing opening inother embodiments) of the ALTC device 8 from a radially compressed to aradially expanded configuration. In some embodiments, the proximal endopening of the ALTC device 8 includes a capture guide 11 that takes theform of, in some embodiments, a radially expandable shape memory partialor full ring-like annular structure that expands once free of thesidewall of the outer tube 1 along with a portion of the ALTC devicemesh 8 attached to the capture guide 11. In the illustratedconfiguration, however, a significant portion of the surface area and/orthe axial length of the mesh of the ALTC device remains in a compressedconfiguration within the lumen of the capture catheter 4, as the otherend of the ALTC device mesh 8 is still operably attached, such as fixedto the outer diameter sidewall of the guidewire catheter 6.

FIG. 4 illustrates a close up view of the distal end of the ALTCcatheter system 35 in the delivery configuration including the distalend 1001 of the outer sheath 1 and nose tip 7, which can be atraumaticand tapered as shown, according to some embodiments of the invention.

The ALTC Device 8 can function to retrieve and capture materials such asthromboemboli. The capture catheter 4 is shown, along with the ALTCDevice 8, capture catheter shaft body 12, pull wire 10, and thrombuscapture guide 11.

As illustrated in FIGS. 5-9 for example, a thrombus capture guide 11 canattach to a portion, such as an open end of the ALTC Device 8 and one,two, or more capture pull wires 10 where the capture pull wires arepositioned inside the side lumen of the suction catheter 2 or outside ofthe lumen in other embodiments, and extends proximally. The distal endof the capture pullwire 10 can be connected to the proximal end of theALTC device 8 at the capture guide 11 as illustrated. The capturepullwire 10 can extend proximally through the length of the outer sheath1, and the proximal end of the pullwire 10 can be pushed or pulled allowa user to control, such as adjust the axial length of the ALTC device 8,for example when axially elongating the ALTC device in a proximaldirection. In some embodiments, the capture pullwire 10 and the captureguide 11 are the only elements attached to the proximal end of the ALTCdevice 8. In some embodiments, the capture pullwire 10 and the captureguide 11 can be made into a single component such as a Loop. In someother embodiments, the capture guide and the proximal end of the ALTCdevice is sutured in place using silk or polymeric filaments such asUltra-High Molecular Weight polyethylene, Nylon, PET, PTFE. In someembodiments, the open end of the ALTC device is covered with a lowdurometer film or coating and is then folded over the capture guide 11and suture to secure the assembly. In another embodiment, the open endof the ALTC device 8, capture guide 11 and sutured assembly is coatedwith a low durometer polymeric materials. Another method to secure thewire ends is to apply polymeric fabric either on the outer or innersurface of the tubular structure and secure via suturing in place withsuture filaments. The fabric can be at least one piece initially wrappedeither on the inner or outer surface of the tubular structure and thenfolded over to the opposite side to secure and protect with wire ends.The two sides of the fabric can secured to the tubular structure usingsuture filament. Other means of securing the fabric to the tubularstructure such as thermal bonding, press, lamination, chemicals,mechanical securement, and lasers can be used in some embodiments. Theclosed end of the ALTC device can be attached to an outer surface of theguidewire tube 6, which in turn can be positioned within a lumen of thecapture catheter shaft 12. As such, axial elongation of the ALTC devicein a distal direction can be achieved by, for example, movement of theguidewire tube 6 and pullwire 10 distally with respect to the capturecatheter shaft 12. The axial elongation of the ALTC device in a proximaldirection can be achieved by, for example, movement of the capturepullwire and capture catheter shaft proximally. The Thrombus CaptureGuide 11 can be formed, for example, from metallic, shape memory, orother appropriate materials. In some embodiment, the thrombus captureguide 11 can include a loop configuration and be formed from nitinolshape memory wire of various geometries such as round, oval, elliptical,flat, and the like. The thrombus capture guide 11 can be formed ofdifferent shapes such as a circular loop, oval loop, z-shape, etc. Insome embodiment, the loop 11 can be shaped set either into coils,multiple full circles, full circle or partial circles where the ends ofthe wire formed into two legs. The partial circle can be from, forexample, 180 degrees to 359 degrees or 220 degrees to 359 degrees. Thelegs can be configured to be off-axis to the loop such that it can beright angle, acute or obtuse angle relative to the loop. It can bearcuate and form a partial or full ring as illustrated, and cancircumscribe or otherwise form an outer diameter, and define theproximal-most end of the ALTC Device 8. The thrombus capture guide 11can in some embodiments include a single loop or multiple loopspositioned along the length of the ALTC Device 8 and not necessarily bepresent or have the entire guide 11 at the proximal-facing end openingend of the ALTC device 8. In some embodiments, the thrombus captureguide 11 does not include a loop. The ALTC Device tubular structure canbe configured to be compressed and positioned within the CaptureCatheter Shaft 12 lumen during introduction into the vascular systemwhere the Capture Catheter Shaft 12 is configured to be positionedcoaxially within and extend through the tubular structure and thrombuscapture guide 11.

As illustrated in FIG. 5, the Axial Lengthening Thrombus Capture Device(ALTC Device) 8 can be in some embodiments a generally tubular net-likemesh structure that is collapsible, expandable and configured to axiallylengthen or shorten, such as within a working range, while maintainingor substantially maintaining its diameter within the working range toretrieve and capture foreign or otherwise unwanted materials within thebody, including the vascular system such as blood clots, thrombus and/orforeign materials.

As shown, for example, in FIG. 6, it can also be possible to lengthenthe ALTC Device 8 in an appropriate direction, such as distally, bypushing the capture catheter 12 relative to the guidewire shaft 6,thereby allowing additional reserve radially compressed length of thetubular mesh 8 to radially expand out of the confines of the lumen ofthe capture catheter 12 to axially lengthen the Thrombus Capture Device8 and maintain its constant or substantially constant diameter through aworking range. The other end of the ALTC device 8 at its radiallycompressed end can be fixed to the outer sidewall of the guidewire tube6. A combination technique of, for example, manipulating the CapturePull wire 10 attached to the Capture Catheter shaft 12 movement (FIG. 6)can position the ALTC device at a desired location within the bodylumen, and movement of the guidewire catheter 6 axially with respect tothe capture catheter shaft 12 will also axially lengthen or shorten theALTC Device 8 while maintaining its diameter through a working range.When the ALTC Device 8 is in the deployed (expanded) configuration, theALTC Device 8 can also be stretched beyond the working range to anextended axial length to reduce its diameter.

FIG. 7 illustrates the axial lengthening thrombus capture device 8 isfully deployed such that the attachment site 128 of the ALTC device 8 onthe guidewire lumen 6 outer diameter is distal to the distal end of thecapture catheter shaft 12 and the funnel tip 9 of the suction catheteris positioned within the ALTC, according to some embodiments of theinvention.

FIGS. 8 and 9 illustrate different views of the initial deploymentposition of the ALTC Device 8 and the funnel tip of the optional suctioncatheter 2, according to some embodiments of the invention.

FIG. 10 illustrates the partially deployed ALTC Device, according tosome embodiments of the invention, where the ALTC device 8 is axiallylengthened while maintaining its width normal to the axial direction.

FIG. 11 illustrates an ALTC device deployed configuration where thefunnel tip of the suction catheter is positioned inside the ALTC device,according to some embodiments of the invention.

As illustrated, a Guidewire Lumen Assembly 6 can include a nose tip 7,shaft, lumen, and a proximal connector and port where a guidewire can beinserted therethrough. The central lumen can have a distal opening insome embodiments The guidewire tube 6 can be used to navigate and trackover the guidewire in the vascular system. The guidewire tube 6 canextend coaxially within the lumen of the catheter shaft 12. A nose tip 7can form or otherwise connect to the distal end of the guidewire tube 66 shaft to aid tracking the system through the vascular system, and canbe atraumatic in some embodiments. The guidewire tube 6 can be made ofpolymeric materials such as, and not limited to Polyimide, Nylon,Polyurethane, Pebax, Polyethylene, PET, PTFE or ePTFE. The guidewiretube 6 can have, in some embodiments, radiopaque markers along itslength for use to indicate the location of the ALTC Device, initialdeployment, partial deployment, final deployment, the percent of lengthdeployed and/or any combination thereof.

FIG. 12 illustrates the Axial Lengthening Thrombus Capture (ALTC)assembly 8 without the outer sheath, capture catheter 4, or guidewirecatheter 6 present for clarity. As illustrated, end 800 withproximal-facing opening 802 of the ALTC device 8 is in the expanded(deployed) configuration and is fixed to the thrombus capture guide 11and capture pullwire 10, according to some embodiments of the invention.For purpose of illustration, a reserve portion of unexpanded mesh 81including end 804 is in a collapsed configuration and extends proximallytoward attachment site 128.

In some embodiments, the tubular mesh structure 8 can axially lengthenor shorten without reducing or substantially reducing its diameterthrough a working length/axial range because the radially expandedportion of the tubular mesh structure is subject to none or minimaltension as it elongates or shortens axially through that axial workingrange. Not to be limited by theory, this can be accomplished at least inpart because the tubular mesh structure can elongate axially throughoutthe working range by unrolling, everting, or otherwise expanding ortransforming a radially compressed reserve segment of tubular mesh, suchas unexpanded mesh 81. As such, an expanded “end” opposite the end ofthe radially expanded device with the capture guide and proximal endopening, such as dynamic fold point 88 of the radially expanded portionof the tubular mesh 8 may not be the absolute end of the tubular meshfixed to a tubular shaft at zone 128, but rather an intermediate dynamicfold point 88 that is not fixed at that point to a tubular shaft, and assuch not under any, or not substantially under any tension. The radiallycompressed reserve segment of tubular mesh 81 thus extends back in adifferent or the opposite direction (e.g., proximally in some cases) andends at the terminal fixation point to the tubular shaft (e.g., atlocation 128). If it has not exceeded the working length of the expandedtubular shaft, the distance between the dynamic fold point 88 and thedistal end of the entire catheter system (e.g., the nose tip) canincrease as the radially expanded portion of the tubular mesh 8lengthens, and the radially compressed reserve segment is used up.

Once the compressed reserve segment 81 of tubular mesh 8 is nearly orcompletely expanded to, or almost to its actual end at 128 and thetubular mesh 8 is axially elongated beyond its working length range,further axial elongation can start to exert significantly increasedtension on the fully axially expanded tubular mesh structure 8, causingit to assume a configuration in which it radially contracts as itfurther axially lengthens.

A tubular net-like structure with one open end as disclosed above andelsewhere herein can be highly advantageous as a relatively small axialsegment of the tubular mesh can be radially expanded and be fullyfunctional to capture emboli and/or other materials in tight workingenvironments, such as in obstructed body lumens with limited space tomaneuver distal to the treatment location of interest. If it is desiredthat a greater axial length of radially expanded tubular mesh isrequired, such as to capture a relatively long length thromboemboli, thecompressed reserve segment of tubular mesh can be unrolled, everted orotherwise expanded or transformed to a specific axial length as desired.Having a compressed reserve segment that can be stored along the lengthof the catheter system in a compact manner can be very advantageous inproviding a long effective capture length tubular mesh without requiringthe entire capture system to have a long fixed length as would berequired in conventional filters/nets, which can be fixed at both endsand thus are functional and fully radially expanded when the first endis spaced apart from the second end at a single specific axial distance.

As illustrated in FIG. 12, some or most of the axial length of the ALTCdevice, e.g., the tubular mesh structure 8 remains radially compressedas part of the reserve segment between the outer diameter of theguidewire catheter 6 and the inner diameter of the shaft 12 of thecapture catheter (distance between of which is length L12B), with theradially expanded portion of the tubular mesh structure 8 being definedalong the axial length between proximal end 800 with proximal-facingopening 802 and the dynamic fold point 88 (distance between of which islength L12A), the sum of L12A and L12B amounting to the absolute lengthof the tubular mesh 8. In this initial configuration, the length L12B ofthe radially compressed reserve segment 81 can be about, or at leastabout 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or more of theabsolute length of the tubular mesh 8.

FIG. 13 illustrates the axial lengthening thrombus capture device 35 inthe initial deployed configuration, according to some embodiments of theinvention, with the radially expanded segment of the mesh 8 between end800 and dynamic fold point 88 and the reserve compressed segment (notshown) extending axially proximally past end 800 to fixation point 128on the outer surface of the guidewire shaft (not shown). FIG. 14illustrates the thrombus capture element 15 of the ALTC device that caninclude a stent, braided, woven, laser cut, or other mesh such as anet-like structure, according to some embodiments of the invention. Thetubular mesh structure need not necessarily be porous, and can becovered by nonporous or other layers. The ALTC Device tubular meshstructure 8 can be made of any suitable polymeric materials such as butnot limited to polyethylene terephthalate (PET), polyethylene (PE)polypropylene (PP), nylon, silk, UHMWPE, PTFE, Kevlar, cotton, and/ormetallic materials including superelastic material, nitinol, stainlesssteel, cobalt-chromium-nickel-molybdenum-iron alloy, or cobalt-chromealloy, Chronichrome, or Elgiloy. The tubular structure can be braided,extruded, woven, knitted, laser cut, dip, film cast from a polymericand/or metallic flat sheet, metallic filaments, polymeric filament orfabric in some embodiments. The tubular structure can be film cast withlaser cut holes in some embodiments. The tubular structure can also bebraided from polymeric and/or metallic filaments or any combinationthereof. In some cases, the tubular structure can be made of nitinolwire mesh having multiple wire strands. Furthermore, the tubularstructure can include at least one wire strand made of high radiopaquematerial such as tantalum, platinum, gold or nitinol drawn filler tubewith a platinum core to enable viewing the tubular structure underfluoroscopy. In some embodiments, the tubular structure can include one,two, or more radiopaque markers. Depending of the diameter of the ALTCdevice, the number of wire strands can range from, for example, 1 to 576wire strands. The ALTC Device can have 2, 4, 144, 288, or another numberof wire strands in some embodiments. In some embodiment, the ALTC deviceis configured to have one wire strand. The wire strand diameter canrange from, for example, 0.0002″ up to 0.015″. In some embodiments, thewire strand diameter is about 0.001″. The tubular structure can beimpermeable in some sections, permeable in other sections and/or acombination thereof. The tubular structure can be non-coated, or coatedwith one, two, or more anti-thrombogenic agents such as heparin toprevent clotting, or other therapeutic agents. The tubular structure canalso be coated with a hydrophilic or hydrophobic agent. The tubularstructure can have different pore sizes to assist with capturing smallemboli or larger pore sizes to allow perfusion or blood flow. Thetubular structure can have uniform pore sizes through the entire lengthor a combination of different pore sizes along its entire length. Forexample, when utilized as a cerebral protection filter, the ALTC devicepore size can be sufficiently large to capture clinical relevant embolisize as small as, for example, about 200, 175, 150, 125, 100, 75, 50microns or less while maintaining perfusion or blood flow. Duringretrieval, the ALTC device 8 can be repositioned to a particular sectionof the tubular structure that has smaller pore size and retrieve theblood clots/thrombus. In some embodiments, the ALTC device can deployand enmesh within the blood clot to capture the blood clot in, forexample, the neurovascular system. During retrieval, the ALTC device canlengthen sufficiently beyond the captured thrombus to create aprotection filter distal to the captured thrombus. This can beclinically beneficial to prevent thrombus from dislodging duringretrieval and thereby prevent secondary stroke. The ALTC Device tubularstructure 8 proximal end can, in some embodiments, attach to theguidewire tube 6 outer surface, such as near attachment site 128. Insome embodiments the proximal end of the ALTC Device tubular structurecan be wrapped and sutured with polymeric filaments and encapsulatedwith low durometer polymeric material to fixably secure the wire ends tothe shaft, such as the guidewire lumen assembly. Other means ofattachment to secure the wire ends such as mechanically, thermally orchemically bonding the polymer to secure the wire ends can be used. Inanother embodiment, the ALTC Device proximal end can be fixed to theouter surface of the guidewire shaft using adhesive and is sandwichedbetween the outer surface of the guidewire shaft and cover tubes.

FIGS. 15A-C illustrate another embodiment of a clot capture system, adistal portion of the ALTC System and a proximal portion of the ALTCSystem respectively. FIG. 15A schematically illustrates the cathetersystem 35, while FIG. 15B shows the distal nose tip 7 operably connectedto the distal end of the guidewire shaft 6 that includes a lumen for aguidewire to pass therethrough. One end of the ALTC device 8 can befixably attached to the guidewire shaft 6 at one or more locations 128and the other end 800 that includes proximal or distal-facing opening802 is attached to capture guide 11, such as in the form of a loop 11,and it is movable axially distally and proximally via capture guide 11Loop can include, for example, one, two, or more linear segments thatextend proximally from the loop 11 onto the capture catheter shaft 12,which are in turn secured proximally to the capture catheter shaft 12 bya the sleeve 30. The sleeve 30 in some embodiments can be presentinstead of the pullwire(s) extending proximally all the way through thedevice. This can in some cases be advantageous ergonomically and allowfor more streamlined control at the proximal end for a user. The axiallyexpanded length of the tubular mesh 8 is shown extending from end 800 todynamic fold point 88, with the reserve length of compressed tubularmesh (not shown) running proximally along the outer sidewall of theguidewire shaft 6 to its end at fixation point 128. FIG. 15C illustratesan embodiment of the proximal end of the system, including one or moreflush ports 13, hub 55 of the outer sheath 1, hub 155 of the capturecatheter 12, and hypotube pusher 14, and proximal-most hub 15 with alumen configured to slide a guidewire therethrough. The hypotube pusher14 can in some embodiments be coextensive with, such as welded orotherwise attached to the third tubular member (e.g., the guidewire tube6), and when manipulated by an operator effect axial movement of theguidewire tube 6 in a proximal or distal direction. In some embodiments,there can be an integral guidewire tube 6 from the proximal most hub 15to the distal nose tip 7. The third tubular member 14 can be configuredto be placed within a lumen of a second tubular member (e.g., capturecatheter shaft 12), such as at its proximal end at hub 155. The secondtubular member can be configured to be placed within a lumen of a firsttubular member (e.g., outer sheath 1), such as its proximal end at hub55. In some embodiments, hub 55 and hub 155 can include complementarythreads or other reversible locking features to allow for the outersheath 1 to be reversibly coupled to the capture catheter 12 to allowfor axial movement of the two tubular members in concert with eachother. Uncoupling the hubs 55, 155 can allow for axial movement of thecapture catheter 12 with respect to the outer sheath 1 and vice versa.

Still referring to FIGS. 15A-C, in some embodiments as illustrated, if asleeve 30 is present, no separate pullwire extends from the captureguide 11 proximally to the proximal end of the system. In some suchembodiments, axial movement of the capture catheter shaft 12 proximallywith respect to the guidewire tube shaft 6 facilitates radial expansionof at least a portion of the ALTC device 8 and positioning of the ALTCdevice 8 within a body lumen. Axial lengthening and/or shortening of theALTC device 8 in some embodiments can be effectuated by movement of theguidewire tube 6 (of which the other end of the ALTC device not attachedto the capture catheter 12 via sleeve 30 is attached to, such as atattachment site 128) with respect to the capture catheter 12 and/ormovement of the capture catheter 12 with respect to the guidewire tube6.

FIG. 16A illustrates another embodiment of a distal portion of the axiallengthening thrombus capture device 35 in the delivery configuration,according to some embodiments of the invention.

FIG. 16B illustrates the axial lengthening thrombus capture device inthe initial deployed configuration wherein the outer sheath 1 isretracted, e.g., proximally to radially expand an end that includes theproximal-facing opening 802 of the axial lengthen thrombus capturedevice (e.g., tubular mesh 8) to dynamic fold point 88 which serves asthe effective expanded distal end of the tubular mesh 8. The captureguide 11 and associated terminal wires 10 are operably coupled to thesleeve 30, and the sleeve 30 is coupled to the outer wall of the capturecatheter shaft 12, according to some embodiments of the invention. Thecompressed reserve length segment (not shown) of the tubular mesh, suchas about or at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%or more of the absolute axial length of the ALTC device 8 (e.g., tubularmesh) taking into account folds remains inverted, rolled up, and/orotherwise radially compressed and circumscribed by the inner sidewall ofthe capture catheter shaft 12, up to the point where the other end ofthe ALTC device 8 is attached on an outer diameter of the guidewire tube6 at attachment site 128. As illustrated, the dynamic fold point 88varies along the length of the tubular mesh 8 depending on the length ofthe compressed reserve length segment that is expanded. The dynamic foldpoint 88 “floats” and is not directly attached to the guidewire shaft 6nor the capture catheter shaft 12, and as such moves axially proximallywhen the expanded segment of the tubular mesh 8 axially lengthens.

As such, when the guidewire shaft 6 with distal nose tip 7 is maintainedin a constant position, axial elongation of the expanded tubular mesh 8results in an increase in the axial distance D between the distal nosetip 7 and the dynamic fold point 88, so distance D3 is greater than D2,which is in turn greater than D1. Furthermore, as shown in FIG. 16B thefirst end 800 of the tubular mesh is distal to the unexpanded end of thetubular mesh (at location 128) fixed to the outer sidewall of theguidewire tube 6, but moves closer proximally in FIG. 16C and becomesproximal to the unexpanded end of the tubular mesh at FIG. 16D while thedynamic fold point 88 moves proximally but is still slightly distal tothe unexpanded distal end of the tubular mesh 8 in FIG. 16D, where theexpanded axial length is even greater, or in some cases at its maximumworking length. As noted, the diameter/width of the expanded tubularmesh remains constant or relatively constant between FIGS. 16A-D. Uponexhaustion of the compressed reserve segment which has transformed intoexpanded tubular mesh, continued axial expansion can result in increasedtensile forces on the tubular mesh, resulting in a configuration inwhich radial contraction begins to occur.

FIGS. 17A-D illustrate different configurations of the ALTC device,according to some embodiments of the invention. During delivery, thecapture guide 11 (e.g., ring-shaped in some embodiments) connected tothe expanded end 800 of the tubular mesh 8 can be configured to collapsewithin the outer sheath 1 lumen during introduction into the vascularsystem and is configured to radially expand first when the outer sheath1 retracts proximally while the length of reserve tubular mesh structure81 of the ALTC device 8 extending proximally from the dynamic fold point88 to fixation point 128 on the guidewire shaft 6 remains compressed inthe capture catheter shaft 12 lumen. The dynamic fold point 88 serves asthe effective expanded distal end of the tubular mesh 8. Upon furtherretracting the thrombus capture guide 11 via pulling the Capture PullWire 10 (or sleeve 30 as shown) and capture catheter shaft 12proximally, the portion of the ALTC Device 8 tubular structure that iscompressed within the Capture Catheter Shaft 12 lumen expands and cantransform via, e.g., roll out proximally, inversion, and/or eversion,and axially lengthening the ALTC Device 8. Advance of the CaptureCatheter Shaft 12 distally can collapse at least a portion of the ALTCDevice 8 tubular structure into the Capture Catheter Shaft 12 lumen, aspreviously shown in FIGS. 7-9. The ALTC Device's ability to expand, rollout, axially lengthen and maintaining a substantially constant diameterthrough a working range creates a cavity (or pocket) within the sidewallof the radially expanded segment of the ALTC Device 8 to retrieve andcapture foreign materials such as, for example, blood clots/thrombus. Inanother embodiment a sleeve 30 (FIGS. 16A-D and 17A-D) can be used tocouple, such as permanently, the Capture Pull Wire 10 to a portion ofthe Capture Catheter shaft 12 to enable both components to operatetogether. Coupling the Capture Pull Wire 10 and the Capture Cathetershaft 12 can allow the user to manage the capture device moreefficiently and easily. In another embodiment, the capture guide 11takes the form of a loop and can attach to the Sleeve 30, which iscoupled to the Capture Catheter Shaft 12.

FIGS. 18A-B illustrate an embodiment of a distal portion of theaxially-lengthening thrombus capture system with a cover element 80radially outward of, and partially or completely circumscribing thecapture catheter shaft 12 or loop 11 of the ALTC device, which can be inthe shape of a ring as illustrated. In some embodiments, the coverelement 80 can function to protect one or more of the capture guide,ALTC device, and the luminal wall of the lumen being treated. The ring80 can also be configured to provide a seal against the luminal wall,e.g., of the vessel, to prevent leakage or migration or embolization ofunwanted material around the tubular mesh 8. In some embodiments, thecover 80 can also include a skirt portion. The cover 80 can be axiallyand/or radially expandable, such as an inflatable balloon, a softpolymer, a gel, a foam, a textile fabric, shape memory, and/or includeother materials. If the cover 80 is expandable, it can be configured toreversibly contract to allow for fluid flow around the cover 80 once theprocedure is completed. Also as illustrated is sleeve 30 serving toattach the capture guide 11 connected to one or more wires 10. Sleeve 30can include one or more apertures 307 that serve as relativelyradiolucent markers, and/or the sleeve 30 could be made of a radiopaquematerial in some embodiments. Also as illustrated, the capture catheter12 as well as guidewire tube 6 can extend through the tubular mesh 6from first end 800 through dynamic fold point 88. The reserve segment ofcompressed tubular mesh is not shown for clarity.

FIGS. 19A-C illustrate an embodiment of an axially-lengthening thrombuscapture system, configured to allow the guidewire 350 to distally exitthe system prior to exiting the luer/proximal-most port 15 at theproximal end of the system. The guidewire's proximal end can exit thesystem through an aperture or slot 351 in the sidewall once it passesthe reversibly couplable hemostasis seals 55, 155 of the outer sheath 1assembly and the capture catheter 12 respectively. In some embodiments,the guidewire 350 is configured to exit sideways, that is laterally. Insome embodiments, a keyed cap 36 is positioned distal to the hemostasisseals 55, 155, which is in turn proximal to a shaft 14, which can serveas a hypotube pusher connected to or coextensive with the guidewire tubeand be made of metal in some embodiments. The shaft 34 can include asidewall groove 351 fully or partially axially from the port 15 to thehub 155 and/or one, two, or more discrete slots as illustrated.

Such embodiments can be advantageous, for example, to utilize a shorterlength guidewire needed when the delivery system overall lengthincreases. In some embodiments, when the ALTC capture device increase inlength, the hypotube is also lengthened to accommodate thus increase thedistance for user to manage the guidewire and system. The side guidewirefeature can minimize the distance resulting in better handling, and theproximal end of the guidewire 350 need not necessarily extend past theproximal end of the entire system, such as at port 15. As such, theguidewire as part of the system can advantageously have a total lengthin some embodiments that is the same as, or even less than the axiallength of the entire material capture system from proximal port 15 todistal nose tip 7, which may otherwise not be possible

The guidewire 350 can be located near the hemostasis seals 55, 155 areaduring the procedure, and as such the entire procedure/operation can bedone with the user not needing to look down to see where the componentsare located. As such, the user can hold the hemostasis seals 55, 155housing in one hand while at the same time manipulating the guidewire350 and hypotube pusher 14 with the other hand in the general areawithout substantially moving away from the area. The users can hold andmaneuver the hypotube pusher 14 or hold and maneuver the guidewire 350or hold both the hypotube pusher 14 and guidewire 350 at the same time.In some embodiments, the inner diameter of the shaft 14 with groove canbe generally larger than the guidewire 350 that allows the guidewire 350to exit laterally. The keyed cap 36 with a boss profile can mate to thegroove of the metal shaft 14 to prevent the metal shaft 14 from rotatingand still allow the shaft 34 to slide back and forth axially.

In some embodiments, an Expanding Guide Catheter 50 (shown in FIGS.20-21 for example) is a discrete catheter that can be utilized togetherwith the clot capture system, and functions to assist in retrieving theALTC Device 8 (and associated catheter system 35) and capture bloodclots and other undesired materials. In some embodiments, the ExpandingGuide Catheter 50 can include a first tubular member, such as an outersheath 49 with a proximal end, a distal end, a lumen extending from theproximal end and the distal end, and a port on the proximal end, whichcan be coaxial as illustrated or offset from the longitudinal axis ofthe outer sheath 49. A second tubular member, such as inner catheter 54can have a proximal end, a distal end, and a lumen extending from theproximal end to the distal end and can be configured to be placed withinthe lumen of the outer sheath 49. The inner catheter 54 can also have aproximal port, a removable obturator 51 positionable in the innercatheter lumen, distal expandable funnel tip 52, expandable shaftsection 53 proximal to the funnel tip 52, an inner shaft 54, andconnectors with seal 55. The obturator 51 can be used to aid ininserting and navigating the Expanding Guide Catheter 50 in the vascularsystem. The obturator 51 can be made of polymeric materials such asPolyethylene, Nylon, Pebax, Polyurethane, PET or PTFE for example. Theobturator 51 can have a tapered distal end in some embodiments to aid inintroducing the Expanding Guide Catheter 50 in the vasculature or otherbody lumen. Alternatively, other embodiments of the obturator 51includes an expandable member such as a balloon operably connected tothe distal end. Expansion of the expandable member, such as inflatingthe balloon can create a smooth tip transition. The balloon can be madeof polymeric materials such Nylon, Polyurethane, PET, etc. Inflating theballoon can also secure the balloon obturator to the guide catheter suchthat when applying axial load proximally to the obturator shaft willarticulate the tip of guiding catheter. The funnel tip 52, illustratedfor example in FIGS. 20B-C, can include a distal funnel-like segment,and be adjacent to an expandable proximal segment 53 wherein it isconnected to a more proximal portion of the inner shaft 54. The funneltip 52 can be, in some embodiments, made of either polymeric and/ormetallic materials. It can be either tubular in shape, woven or braided.The braid configurations can be, in some cases, 1×1 or 1×2 or 2×1 or 2×2or any combination thereof. The picks per inch (PPI) can range from, insome embodiments, 5 to 60. The number can be, in some embodiments, fromone wire filament up to 288 wire filaments. The wire shape can be round,flat, oval, rectangular or square. The wire diameter can be from 0.0005″up to 0.015″. The flat wire thickness can be from 0.0005″ up to 0.010″and the wire width can be from 0.001″ up to 0.030″. The funnel tip 52distal segment can have various shapes or configurations to allow betterretrieving the blood clots or thrombus. In some embodiments, the funneltip 52 distal segment has a large open end where it contacts the vesselwall when expanded and transitions to smaller opening proximal segment53. The distal segment open end can range from, in some embodiments,about 5 mm to about 80 mm in diameter. The funnel tip distal segment 52also has, in some embodiments, openings or holes (perforations) alongthe side to allow blood flow. The funnel distal segment 52 can haveeither one layer of braid or multiple layers. In some embodiments, thefunnel distal segment has two layers. In some one layer embodiments, themost distal open end of the funnel does not have the wire end terminateor exposed such that the wire ends are located at the proximal end ofthe funnel assembly. The funnel tip proximal segment 53 can beconfigured such that it is capable of expanding and receive the ALTCdevice and captured blood clots or thrombus. The proximal segment 53 canbe configured to expand to receive object that is larger than its innerdiameter and recovery after passage. The proximal segment 53 can includea PTFE inner layer and compliance and/or low durometer polymericmaterials such as Polyurethane, Silicone, Tecoflex, Pebax 25D and/or 35Dor braid and/or non-braided such as Pebax/Propel/BaSO4 outer layer. Theproximal segment 53 can also include other lower durometer polymericmaterials. The composite funnel tip and proximal segment can belaminated via dipped coat, spray or reflow process or any combinationthereof. The braid materials can be either metallic and/or polymerand/or combination thereof. The braid configurations 1×1 or 1×2 or 2×1or 2×2 or any combination thereof. The picks per inch (PPI) can rangefrom, for example, 5 to 60. The number can be from one wire filament upto 288 wire filaments. The wire cross-sectional shape can be, forexample, round, flat, oval, rectangular or square. The wire diameter canbe from 0.0005″ up to 0.015″. The flat wire thickness can be from0.0005″ up to 0.010″ and the wire width can be from 0.001″ up to 0.030″.In some embodiments, an advantageous feature is the ability to expandand contract without buckling under compression. The inner diameter canrange from, e.g., 2 F to 30 F. In some embodiments, the inner diametercan range from, e.g., 6 F to 18 F. The expanded length section can be upto the entire catheter length. In some embodiments, the length is about20 cm. The funnel distal 52 and proximal segment 53 can also be made asone component wherein the braid configuration is continuous. Coupled toor continuous with the funnel tip proximal segment 53, the inner shaft54 can be made from materials such as and not limited to Nylon,Polyurethane, Pebax, Polyethylene, PET, PTFE, or ePTFE. The inner shaft54 can be braided or non-braided. The outer shaft 49 can function toslide over and collapses the funnel tip and provide support duringintroduction into the vasculature. The outer shaft 49 retracts to deploythe funnel tip. The outer shaft 49 can be made of polymeric materialssuch as Nylon, Polyurethane, Pebax, Polyethylene, PET, PTFE, ePTFE, FEPor combination thereof. The outer shaft 49 diameter can range from,e.g., 4 F to 34 F. The outer shaft 49 inner diameter can range from, forexample, 3 F to 32 F. In some embodiments, the inner diameter hassubstantially the same throughout the lumen shaft. In some embodiments,the inner diameter at the distal end is larger than the proximal endinner diameter. The change in inner diameter can be in one location, twoor more locations. The outer diameter is substantially the samethroughout the entire length of the outer sheath shaft. In someembodiments, the outer shaft 49 is about 22 F or smaller in diameter.The outer shaft 49 can include a radiopaque marker at the distal end orradiopaque filler along its shaft length for visibility underfluoroscopy. In some embodiment, the outer shaft can be deflectable(via, for example, one, two, or more pullwires on the distal end) atvarious locations and multiple deflectable directions along the shaftlength to accommodate various tortuous paths such as entry into theright atrium, right ventricle, main pulmonary artery, and left and rightpulmonary artery for pulmonary embolism applications.

Still referring to FIGS. 20A-22C, in some embodiments the expandingguide catheter 50 can be utilized to retrieve blood clots or thrombus.The expanding guide catheter 50 and obturator 51 can be introduced overa wire into the vasculature and advanced near the treatment area. Theobturator 51 is removed. The outer member 49 of the expanding guidecatheter is retracted proximally to expand the funnel tip 52 and theexpandable section 53 of the guide catheter 50. In some embodiments, theguide outer shaft 49 is inserted into the vessel together with theobturator 51 and the obturator 51 is removed once the outer shaft 49 isin a desired position. The inner guide member can include the funnel tip52, proximal segment 53 and the inner shaft 54 is then inserted into theouter shaft 49 up to the distal tip of the outer shaft 49. The outershaft 49 can then be retracted (or the inner shaft 54 advanced) toexpand and deploy the distal funnel 52 and the proximal segment 53. Thecapture catheter system 35 is inserted over the wire and through thelumen of the expanding inner guide member 54. Once the ALTC Device 8 isdeployed and captures the blood clots, the ALTC Device 8 is retractedalong with the captured blood clots into the funnel tip 52 and expandingguide inner member 53, (shown later in FIG. 50). When high resistance isencountered at the funnel tip due to the large blood clot position atthe tip, the guidewire lumen can advances distally to lengthen the ALTCDevice. Lengthening the ALTC device can create additional space withinthe ALTC device such that the blood clot volume is redistributed therebyreduces the large blood clots pooled at the tip of expanding guidecatheter. The expanding guide catheter distal section also allows largerclots to be captured due to its expandability increasing the lumen size.Continuing to retract the ALTC device will retrieve additional capturedblood clots inside the expanding guide catheter. Repeated lengthening ofthe ALTC during the procedure will continue to redistribute the clot andretrieve inside the Expanding Guide Catheter, advantageously allowingfor improved thrombus processing and redistribution. In someembodiments, a kit can include a capture catheter system 35 as describedherein and configured to be reversibly placed within, and move axiallywith respect to an inner lumen of a discrete expanding guide cathetersystem 50 as described herein.

FIG. 21D illustrates an embodiment wherein a cover tip 710 encapsulatesthe distal end of the outer cover of the expanding guide cathetersystem, according to some embodiments of the invention.

FIGS. 22-24 illustrate the outer sheath assembly 1 of the capturedevice, according to some embodiments of the invention. The outer sheath1 can function to contain, protect, and deliver the Axial LengtheningThrombus Capture Device (tubular mesh 8 (not shown) to the desiredanatomical location, such as in a radially compressed configuration. Asshown in FIG. 22, the Outer Sheath 1 can include a soft atraumaticdistal tip, a shaft body that can be tubular in some embodiments, aninterior channel/lumen configured to house and reversibly couple at itsproximal end a second tubular member, such as a capture catheter asdescribed elsewhere herein, and a proximal connector with a seal 55 andflush tube/port 13. The Outer Sheath 1 can be made from suitable medicalgrade materials, including but not limited to Nylon, Polyurethane,Pebax, Polyethylene, PET, PTFE, ePTFE, PEEK, PEBAX/Propell andpolypropylene. The polymeric materials can include radiopaque materialssuch as, for example, barium sulfate, bismuth subcarbonate or bismuthtrioxide to enable viewing under fluoroscopy. The radiopaque materialscan form one, two, or more discrete marker elements in some embodiments,such as at the distal tip, and/or spaced apart at regular or irregularintervals along the length of the outer sheath 1. The outer diameter ofthe outer sheath 1 can range from, for example, 3 F to 30 F. The innerdiameter of the outer sheath 1 can range from, for example, 2 F to 28 F.In some embodiments, the inner diameter is substantially constantthroughout the interior channel, e.g., the lumen shaft. In someembodiments, the inner diameter at the distal end is about or at leastabout 10%, 20%, 30%, 40%, 50%, or more than the proximal end. The changein inner diameter can be, for example, stepwise or gradual in onelocation or two or more locations. The outer diameter can besubstantially the same the entire length of the catheter, in someembodiments. The outer sheath 1 working length can be, in some cases,from about 10 cm to about 150 cm. In some embodiment, the Outer Sheath 1working length is about 135 cm in some embodiments. The Outer Sheath 1shaft can be braided or non-braided. In some embodiments, the OuterSheath 1 shaft can be deflectable (via, for example, one, two, or morepullwires on the distal end) at various locations and multipledeflectable directions along the shaft length to accommodate varioustortuous paths such as entry into a left or right heart atrium, heartventricle, main pulmonary artery, and left and right pulmonary arteryfor pulmonary embolism applications, or a vein such as the greatsaphenous vein, superficial femoral, common femoral, SVC, IVC, or otherupper or lower extremity, visceral, or other superficial or deep veinsfor deep venous thrombosis removal applications. The distal end of theshaft of the outer sheath 1 can be configured to deflect up to 360degrees in some cases. Additionally, the distal tip of the Outer Sheath1 can be configured to deflect or bias toward or away from the vesselwall. The distal tip of the outer sheath 1 can include one, two, or moreradiopaque markers to indicate tip location. Alternatively, the distaltip can include radiopaque materials such as, for example, BariumSulfate, Bismuth Subcarbonate or Bismuth Trioxide. FIGS. 23 and 24illustrate the distal end and proximal end of the outer sheath assemblyrespectively. As shown in FIG. 26, the proximal end of the outer sheath1 connects to the outer sheath connector 55 with seal and coupler to acapture catheter connector, and flush port 13.

FIG. 25 illustrates the capture catheter assembly 12, according to someembodiments of the invention, showing catheter shaft 12 and outer sheath1. FIG. 26 illustrates the proximal end of the capture catheter,according to some embodiments of the invention, showing a connector withseal 155 operably connected to a flush port 13.

FIG. 27 illustrates an embodiment of a key cap 36 feature to prevent orinhibit rotation of the hypotube pusher 14. As illustrated, the key cap36 can be a tubular member with a lumen to fit the hypotube pusher 14therethrough. The lumen is non-circular in some embodiments, and/or havea non-circular zone, or otherwise configured to prevent or limitrotation. In some embodiments, the lumen includes teeth or otherprojections into the lumen as shown to prevent undesired rotation of thehypotube pusher. In some embodiments, the lumen or a portion thereof hasa square, rectangular, triangular, oval, pentagonal, hexagonal, or othernon-circular geometry, and configured to limit rotation.

In some embodiments, as illustrated in FIGS. 28-29 for example, anoptional suction catheter 2 can function to aspirate thrombus within theALTC Device 8. The suction catheter 2 can include in some embodiments adistal funnel tip 9, elongate shaft body 16, and proximal connector withseal 3. FIG. 30 illustrates a close-up view of the funnel tip 9 whichcan be attached at the suction catheter shaft 16 distal end to aid inretrieving the thrombus and allow efficient suction. The funnel tip 9can be made of, for example either polymeric and/or metallic materials.It can be tubular in shape, woven or braided, in some embodiments.Funnel tip 9 can be in various configurations to allow better retrievaland suction. In some embodiments, the funnel tip 9 has a funnel shapewith a first, larger distal diameter, a transition section, and asecond, smaller proximal diameter as illustrated. The suction cathetershaft 16 creates a pathway for the aspirated thrombus to travelproximally and exit the body and in some embodiments into the optionalfilter collection chamber. The shaft can be of various diameters,lengths and/or geometries to aid in the removal of materials such asblood clots. The suction catheter shaft can be made from suitablematerials such as and not limited to Nylon, Polyurethane, Pebax,Polyethylene, PET, PTFE, ePTFE, PEEK, and polypropylene. In someembodiments, the suction catheter Shaft distal end is expandable so toaccommodate large amount of blood clots. The suction catheter 2 canattach to the proximal end of filter collection chamber 5 to enablethrombus aspiration (or removal). In some embodiments, the suctioncatheter shaft 16 is deflectable at one, two, or more locations alongthe shaft length to accommodate various tortuous paths such as entryinto the right atrium, right ventricle, main pulmonary artery, and leftand right pulmonary artery. A proximal flush port 13 is alsoillustrated.

In some embodiments, a mechanical thrombectomy tool such as macerator 19shown in FIGS. 32-41 for example, can function to disrupt and break upthe thrombus within the ALTC Device 8. The macerator 20 can include adisruptor 19, shaft 22 and proximal connector with seal 21. AdjustableTouhy knob 23 distally is also shown just proximal to disruptor 19. Thedisruptor 19 can be attached to the distal end of the shaft 22. Themacerator 20 can have various end effector tip configurations asillustrated in FIGS. 35-41 depending on the desired clinical result tobreak up the thrombus within the ALTC Device 8, including a bulbousshape (FIG. 36), proximal and distal bulbs with a narrow waist (FIG.37), a plurality of proximal and distal bulbs with a narrow waist eachoffset by an angle, such as about 90 degrees (FIG. 38), a flower petaldesign with petals radiating radially outwardly from a central hub (FIG.39), a hemi-petal design (FIG. 40), or a substantially linear designorthogonal from the longitudinal axis of the shaft 22 (FIG. 41). Thedisruptor 19 collapses during insertion through the suction catheter 2system and expands once exiting the catheter. The disruptor 19 can bemade of, for example, metallic materials such as stainless steel,Nitinol, cobalt chrome, etc. The macerator can be activated either bymanual rotation, manipulation and/or a motorized handle.

To macerate the thrombus, the macerator 19 is inserted through thesuction catheter 2 and position within the ALTC Device 8. A manualtechnique applies to the luer connector 21 of the macerator 19 byrotating the luer connector 21 causing the disruptor 20 to rotatethereby breaking up the thrombus. Alternatively, the macerator 19 can beused with a motorized handle (not shown). Traversing the disruptor 20axially through the entire length of the ALTC device 8 can aid inbreaking up the thrombus.

The filter collection chamber 5 (FIG. 42) can function to suction andcollect the blood clots. The filter collection chamber 5 can include,for example, a collection chamber 325, filter 324, plunger 323, inflowport 327 and outflow port 326. The filter collection chamber 5 can havean outflow port 326 attaching to the suction catheter 2 connector and aninflow port 327 where a syringe or a similar device can attach foraspiration. The collection chamber 325 has a filter system 324 residinginside the chamber 325 to allow filtering the blood and thrombus. Thechamber 325 also has a plunger 323 for use in injecting fluid such assaline to fill the chamber 325 and push filtered blood back into thevasculature. The plunger 323 can serve as a seal on one side of thechamber.

To aspirate the thrombus from the system, the suction catheter 2 isattached to the filter collection chamber 5 (FIG. 42). A large syringeattaches to the proximal end of the filter collection chamber 5.Applying suction using the syringe causes the thrombus and blood clotsto migrate into the filter collection chamber 5. Once all the thrombusis contained within the chamber 5, close stopcock, detach the syringeand fill with saline and reattach the syringe to the filter collectionchamber 5. Alternatively, an extension tube and external saline filledsyringe can be used to fill saline into the suction syringe. Injectingvia the syringe will push saline into the chamber 325 causing theplunger 323 to push the blood back into the vasculature. The chamber 325will return the blood and leave the thrombus inside the chamber 325.Alternatively, the filter collection chamber 5 can be detached withoutreturning filtered blood to the system. Once the thrombus is removed,retract the suction catheter 2 inside the outer sheath 1. Retract theALTC Device 8 into the outer sheath 1 and remove the entire system fromthe body.

Catheter systems as described herein can be utilized for a variety ofindications depending on the desired clinical result. In someembodiments, the use is not limited to venous systems and can apply toother arterial, venous, or nonvascular areas such as neurovascular,peripheral vascular, cardiovascular, temporary embolic protection devicefor a cardiovascular procedure such as valve replacement, carotidprotection, pulmonary protection during deep vein thrombectomy orembolectomy), or retrieval of an implant, medical device, or othermaterial.

FIG. 43 illustrates a blood clot lodging in the left side of thepulmonary system. Shown is the right pulmonary artery 251, leftpulmonary artery 252, inferior vena cava 253, left iliac artery 254,right iliac artery 255, a pulmonary embolus 256 in the left pulmonaryartery 252 distally, and the superior vena cava 257.

FIGS. 44A and 44B illustrate blood clots residing in the left sidepulmonary system and the capture device respectively, according to someembodiments of the invention. In addition to the anatomical featuresillustrated in FIG. 43, also shown is the guide catheter 264, rightventricle 266, and right atrium 267. As shown in FIG. 44B, capturedevices as described and illustrated herein can advantageously beutilized when there is very limited distal space, as the device isfunctional throughout a wide working axial range as discussed elsewhereherein.

FIGS. 45-47 illustrate capture of a thrombus within a vessel, accordingto some embodiments. FIG. 45 illustrates the initial deployedconfiguration of the axial lengthening thrombus capture device (e.g.,tubular mesh) 8 with end 800, dynamic fold point 88, and reserveradially compressed segment (not shown) terminating proximally at point128 where the radially compressed segment is fixably attached to theouter sidewall of the guidewire lumen 6 is shown. The expanded segmentof the tubular mesh 8 is positioned distal to the thrombus 73 occludedarea and the expanding guide catheter 50 including distal funnel tip 52with proximal expandable section, inner catheter 54 and outer catheter49, or in some embodiments suction catheter funnel tip positionedproximal to the thrombus occlusion 73, according to some embodiments ofthe invention. In some embodiments, expanding guide catheter 50 asdescribed elsewhere herein or a suction catheter can be utilizeddepending on if suction is desired. Also shown proximally is innersheath 54 and outer sheath 49 of expanding guide catheter 50. Actuationof capture pullwire 10 alone or with capture catheter 12 such as axiallyin an appropriate direction (or capture catheter coupled to the outersheath (not shown) in embodiments with a sleeve as previously described)can result in axial lengthening or shortening of the ALTC device 8depending on the desired clinical result. FIG. 46 illustrates the axiallengthening tubular mesh 8 expandable segment lengthening proximally tocapture the thrombus, according to some embodiments of the invention,with the associated radially compressed segment shortening reciprocally.FIG. 47 illustrates the axial lengthening thrombus capture devicecompletely capturing the thrombus, and the expanding guide catheterfunnel tip or alternatively the suction catheter funnel tip is insidethe axial lengthening thrombus capture device. Subsequent suction viathe suction catheter 2 in embodiments where suction is utilized can beperformed to remove the blood clot or thrombus. The ALTC Device canlengthen to have a maximal length that covers the entire length ofcatheter system from, e.g., about 0.5 cm to about 125 cm. In someembodiments, the ALTC device may lengthen to about or at least about 2,3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, or more centimeters.Depending on vessel diameter, the outer diameter of the ALTC device canrange from, in some embodiments, about 1 millimeter up to about 80millimeters. For example, large vessels such as the inferior vena cava,superior vena cava, descending, and ascending aorta, the diameter canrange up to about 60, 70, 80, 90, 100 millimeters or more. Small vesselsin the neurovascular system can be, for example, as small as about orless than about 5, 4.5, 4, 4.5, 3, 2.5, 2, 1.5, 1, 0.5, or lessmillimeters in diameter. The diameter of the ALTC device can achieve thesimilar effect of reducing or stretching the ALTC device diameter. Insome embodiments, suction is not utilized or required, and the ALTCdevice envelops the clot, which can be mechanically pulled back into thecapture catheter.

FIG. 48A illustrates another delivery configuration of the clot capturesystem 35 that can include features as previously described, accordingto some embodiments of the invention. FIG. 48B illustrates the initialdeployment position of the axial lengthening thrombus capture device,according to some embodiments of the invention, and reversible couplingof the hub 55 of the capture catheter 155 to the hub 55 of the outersheath. FIG. 48C illustrates the further lengthening of the expandedsegment of the axial lengthening thrombus capture device, according tosome embodiments of the invention, with reciprocal shortening of thereserve compressed segment 81. As illustrated, the guidewire tube 6 withnose tip 7 is maintained in position while the capture catheterreversibly coupled to the outer sheath can be withdrawn proximally. FIG.48D illustrate the final deployment of the axial lengthening thrombuscapture device at its maximal working length, according to someembodiments of the invention.

In some embodiments, systems and devices as disclosed herein can involvea general percutaneous technique, a cut-down procedure, or minimallyinvasive technique such as transapical, thoracoscopic, laparoscopic, orother techniques, for example, and not limited to transfemoral,transradial and/or internal jugular venous access. The technique canalso apply to the arterial system, including neurovascular,cardiovascular, and peripheral vascular applications, as well as for useas an embolic protection device such as for a cardiovascular proceduresuch as valve replacement or repair for example. In some embodiments, athrombectomy system can be delivered downstream of the aortic root, suchas prior to the aortic arch, and a variable-length shape memory meshstructure such as an ALTC device with an open proximal end and closeddistal end expanded prior to the index cardiovascular procedure, tocapture downstream emboli, calcifications, or other debris. In someembodiments, the system can be deployed to prevent embolization during adeep vein thrombectomy or pulmonary embolectomy, for example. In anotherembodiment, the system can be deployed to prevent embolization orretrieval during acute ischemic stroke. Systems and methods as disclosedherein can also be utilized in non-vascular anatomy such as the biliarytree to capture gallstones, common bile duct stones, and pancreatic ductstones, for example, in the ureters or bladder to capture kidney stones,or in the fallopian tubes to capture ova or other materials. Describedherein are some embodiments of using the venous system to access thepulmonary artery to treat pulmonary embolism. The technique can alsoapply to other areas of the vasculature. Initial puncture to access thefemoral vein. A short access guidewire is inserted into the femoralvein. Next, an appropriate 5 F or 6 F introducer sheath is inserted. Theguidewire is exchanged for a 180 cm, 260 cm or 300 cm guidewire andadvance pass the inferior vena cava, right atrium, right ventricle andthe pulmonary artery to access the occluded treatment area. A longerlength introducer/guiding catheter may be necessary to cross thetricuspid and pulmonary valve. Once the guidewire passes through theoccluded treatment area, the 5 F or 6 F introducer sheath is exchangedfor a long guiding catheter and position proximally near the occludedarea. The catheter system 35 is inserted over the wire and through theguiding catheter and advance distally to the occluded area. The cathetersystem 35 can also utilize the outer sheath deflectable features tonavigate through the vasculature without the use of a guiding catheter.Next, the catheter system's nose tip 7 passes through the occludedtreatment area and positioned distal to the occluded treatment area. TheOuter Sheath 1 is retracted to deploy the thrombus capture guide 11. Theouter sheath 1 is retracted past the thrombus and positioned proximal tothe thrombus (occluded area). The Suction Catheter 2 advances distallyoutside the Outer Sheath 1 and positions proximally to the occludedarea, if suction is utilized.

To retrieve and capture materials such as blood clots or thrombus, theThrombus Capture Guide 11 retracts by pulling the Capture Pullwire 10proximally while push/pull Capture Catheter 12 to axially lengthen theALTC Device 8 over the thrombus without substantially decreasing thedevice diameter. As needed, advancing the Capture Catheter shaft 12distally while pulling the Capture Pullwire will allow the ALTC Device 8to axially lengthen to capture the thrombus. Furthermore, the expandableFunnel Tip 9 of the Suction Catheter 2 (or the funnel tip of theexpanding guide catheter) can be positioned at the proximal end of theoccluded area to support and minimized thrombus movement. This maneuvercontinues until all thrombus is inside the ALTC Device 8. Once thethrombus is completely within the ALTC Device 8, pulling the ALTC Device8 away from the occluded area can restore immediate blood flow whilecontaining the thrombus inside the ALTC Device 8.

In some embodiments, the capture catheter shaft 12 and the guidewiretube 6 are configured to be positioned side-by-side adjacent (e.g.,offset and not coaxial, and not passing within the opening 802 or otherradially expanded portion of the tubular mesh 6) to the ALTC Device 8and capture guide (shown, for example, in FIGS. 49A and 49B). Alsoillustrated is the dynamic fold point 88, reserve radially compressedsegment 81 and compressed end at 128 fixed to the outer wall of theguidewire tube 6.

FIG. 50A-50G illustrate the retrieval of thrombus into the expandingguide catheter wherein the ALTC device lengthens distally and createsadditional space and the thrombus is redistributed and enable betterretrieval into the expanding guide catheter. The funnel tip 52 andexpanding section 53 of the expanding guide catheter also facilitate theease of thrombus retrieval. For example, when the ALTC Device (e.g.,tubular mesh 8) captures the blood clot inside, the ALTC Device 8 canadvantageously stretch axially and compress radially beyond its workinglength (e.g., when the reserve radially compressed segment has beencompletely expanded, and/or by distal advance of the guidewire tube 6),effectively squeezing the blood clot radially to decrease itsdiameter/width. Fresh blood clots are typically soft and deformable.Applying axial stretching to the ALTC device can squeeze out the fluidthat is within the blood clot, thereby reducing the size of blood clotand allowing blood clots to be removed from the vascular system moreeasily. The ability of the ALTC Device to lengthen dynamically alsoprovides another clinically effective way to remove the large clotburden by redistributing the volume of blood clot or thrombus, as shown,for example, in FIG. 50A-50G. For example, with respect to currentinterventional devices such as filters and baskets, when blood clots orthrombus is collected and retrieved into a catheter such as a guidingcatheter or sheath, the blood clot or thrombus can gather together orpooled at base of the filter or basket into a large “ball-like” shapeand prevent the large “ball-like” thrombus to enter the lumen of theguiding catheter or sheath. A similar effect can occur whenaspiration/suction is attempted using a smaller inner diameter guidecatheter. However, the ALTC device can lengthen serially from the distalend to create additional length and space within the ALTC Device (asshown, for example, in FIGS. 50B, 50D, and 50F). By lengthening the ALTCDevice's distal end, the blood clot or thrombus is redistributed withinthe ALTC device thereby reducing the ball-like size of the blood clot,thrombus, or other material for better retrievable inside the guidingcatheter lumen (FIGS. 50C, 50E, 50G). These steps can be repeated for 2,3, 4, 5, or more cycles until all the blood clot and thrombus isretrieved in the catheter in a compacted form. Furthermore, the use ofan expanding guide catheter with an expandable distal section in concertwith the ALTC device can allow more efficient blood clot or thrombusremoval, as illustrated, for example, in FIGS. 50A and 50C. Theeffectiveness of the ALTC Device 8 can be further demonstrated in anextreme vascular condition where there is minimal to no distal spaceavailable for conventional thrombectomy catheters to fully axiallyexpand in order to be functional. The distal space beyond the distal endof the thrombectomy system can be in some cases less than about 3 cm, 2cm, 1 cm, or less. In other words, the ALTC Device 8 can be delivered ina first, radially compressed configuration, and compressed by the outersheath. Upon removal of the outer sheath, the ALTC Device 8 cantransform into a radially expanded configuration and configured tocapture thromboemboli even though the device may be in an axiallycompressed configuration. The ALTC Device 8 can then be axiallyexpanded, such as, for example, at least about 1.25×, 1.5×, 2×, 2.5×,3×, 3.5×, 4×, 4.5×, 5×, 5.5×, 6×, 6.5×, 7×, 8×, 9×, 10×, or more withrespect to its fully functional axially compressed length while stillmaintaining a constant or substantially constant radially expandeddiameter through a working range, such as between about 1 cm and about50 cm, about 1 cm and about 20 cm, or about 1 cm and about 10 cm in someembodiments. In some embodiments, the ALTC device 8 has an open proximalend during delivery, and/or throughout its working axial length. TheThrombus Capture Guide 11 can advantageously deploy initially in thetight space while the ALTC device body remains inside the CaptureCatheter shaft 12. Subsequently, the Thrombus Capture Guide retractsproximally to begin deploying the ALTC Device 8. The potential axiallyexpanded length of the ALTC Device 8 is not necessarily limited and insome embodiments could extend to the entire length of the cathetersystem. The ALTC Device 8 can be collapsed and contained within theCapture Catheter shaft 12 and Outer Sheath 1 during introduction intothe vasculature and expands when the Outer Sheath 1 retracts proximallyto deploy the ALTC Device 8. The Capture Catheter shaft 12 can be madefrom suitable materials such as and not limit to Nylon, Polyurethane,Pebax, Polyethylene, PET, PTFE, ePTFE, PEEK, polypropylene. It is alsoadvantageous and possible in some embodiments that the Capture Cathetershaft 12 is deflectable at various locations and multiple deflectabledirections along the shaft length to accommodate various tortuous pathssuch as entry into the right atrium, right ventricle, main pulmonaryartery, left and right pulmonary artery as previously described.

Various other modifications, adaptations, and alternative designs are ofcourse possible in light of the above teachings. Therefore, it should beunderstood at this time that the inventions may be practiced otherwisethan as specifically described herein. It is contemplated that variouscombinations or subcombinations of the specific features and aspects ofthe embodiments disclosed above may be made and still fall within one ormore of the inventions. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with an embodiment can be used in allother embodiments set forth herein. Accordingly, it should be understoodthat various features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed inventions. Thus, it is intended that the scopeof the present inventions herein disclosed should not be limited by theparticular disclosed embodiments described above. Moreover, while theinventions are susceptible to various modifications, and alternativeforms, specific examples thereof have been shown in the drawings and areherein described in detail. It should be understood, however, that theinventions are not to be limited to the particular forms or methodsdisclosed, but to the contrary, the inventions are to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described. Any methods disclosedherein need not be performed in the order recited. The methods disclosedherein include certain actions taken by a practitioner; however, theycan also include any third-party instruction of those actions, eitherexpressly or by implication. For example, actions such as “inserting acatheter transfemorally” includes “instructing the insertion of acatheter transfemorally.” The ranges disclosed herein also encompass anyand all overlap, sub-ranges, and combinations thereof. Language such as“up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“approximately”, “about”, and “substantially” as used herein include therecited numbers (e.g., about 10%=10%), and also represent an amountclose to the stated amount that still performs a desired function orachieves a desired result. For example, the terms “approximately”,“about”, and “substantially” may refer to an amount that is within lessthan 10% of, within less than 5% of, within less than 1% of, within lessthan 0.1% of, and within less than 0.01% of the stated amount.

1. A clot capture system, comprising: a first, outer tubular shaftcomprising a central lumen, the first outer tubular shaft comprising aproximal portion and a distal portion, the distal portion more radiallyexpandable than the proximal portion; a second tubular shaft configuredto be positioned within the central lumen of the first shaft; a thirdtubular shaft configured to be positioned within a central lumen of thesecond shaft; a shape memory tubular body comprising a first end, asecond end, and an axial length therebetween, the first end having aproximal-facing opening and a ring-shaped capture guide attached to acircumference of the proximal-facing opening, the capture guide operablyattached to the second tubular shaft, the second end attached to anouter wall of the third tubular shaft, wherein the shape memory tubularbody is compressed within the central lumen of the second tubular shaftin a first delivery configuration, wherein the shape memory tubular bodyis transformable to a second configuration in which the first end andthe capture guide are radially expanded but the second end and amajority of the shape memory tubular body remains radially compressedwithin the central lumen of the second tubular shaft and the second endis positioned proximal to the first end and the shape memory tubularbody has a first expanded axial length, wherein the shape memory tubularbody is transformable to a third configuration in which the shape memorytubular body has a second expanded axial length greater than the firstexpanded axial length, wherein a width of the shape memory tubular shaftalong its second expanded axial length is substantially the same as awidth of the shape memory tubular shaft along its first expanded axiallength, wherein the first tubular shaft is configured to be reversiblycoupled with respect to the second tubular shaft in the first deliveryconfiguration and axially movable with respect to the third tubularshaft in the second configuration.
 2. The clot capture system of claim1, wherein the second expanded axial length is at least about 110% ofthe first axial length.
 3. The clot capture system of claim 1, whereinthe second expanded axial length is at least about 125% of the firstaxial length.
 4. The clot capture system of claim 1, wherein the shapememory tubular body is porous.
 5. The clot capture system of claim 1,wherein the shape memory tubular body comprises an impermeable,non-porous polymer.
 6. The clot capture system of claim 1, wherein theshape memory tubular body comprises a semi-permeable porous polymer. 7.The clot capture system of claim 1, wherein the shape memory tubularbody comprises nitinol braided, woven, or non-woven mesh.
 8. The clotcapture system of claim 1, wherein the shape memory tubular body isuncoated.
 9. The clot capture system of claim 1, wherein the shapememory tubular body is coated with a thrombogenic agent.
 10. The clotcapture system of claim 1, wherein the shape memory tubular body iscoated with a hydrophilic or hydrophobic agent.
 11. The clot capturesystem of claim 1, wherein the shape memory tubular body comprisesnitinol wire.
 12. The clot capture system of claim 1, wherein the shapememory tubular body is configured to invert, evert, or roll out withrespect to the third tubular shaft.
 13. The clot capture system of claim1, further comprising a control line extending proximally from thecapture guide.
 14. The clot capture system of claim 1, furthercomprising a suction element configured to operably connect with theproximal opening of the shape memory tubular body.
 15. The clot capturesystem of claim 1, further comprising a mechanical thrombectomy element.16. The clot capture system of claim 14, wherein the mechanicalthrombectomy element comprises a macerator.
 17. The clot capture systemof claim 14, further comprising a filter collection chamber configuredto collect and filter blood obtained from the suction element.
 18. Theclot capture system of claim 1, further comprising an expanding guideelement configured to receive the capture assembly.
 19. The clot capturesystem of claim 18, wherein the expanding guide element comprises anopen funnel distal tip.
 20. The clot capture system of claim 19, whereinthe open funnel distal tip is porous to allow flow.
 21. A clot capturesystem, comprising: a first, outer tubular shaft comprising a centrallumen; a second tubular shaft configured to be positioned within thecentral lumen of the first, outer tubular shaft, the second tubularshaft comprising a proximal portion and a distal portion, the distalportion more radially expandable than the proximal portion; a thirdtubular shaft configured to be positioned within a central lumen of thesecond tubular shaft; a tubular mesh comprising a first end, a secondend, and an axial length therebetween, the first end having aproximal-facing opening and a ring-shaped capture guide attached to acircumference of the proximal-facing opening, the capture guide operablyattached to the second tubular shaft, the second end attached to anouter wall of the third tubular shaft, wherein the tubular mesh iscompressed within the central lumen of the second tubular shaft in adelivery configuration, wherein the tubular mesh is transformable to asecond configuration in which the first end and the capture guide isradially expanded but the second end and a majority of the tubular meshremains radially compressed within the central lumen of the secondtubular shaft and the second end is positioned proximal to the first endand the tubular mesh has a first expanded axial length, wherein thetubular mesh is transformable to a third configuration in which thetubular mesh has a second expanded axial length greater than the firstexpanded axial length, wherein a width of the tubular mesh along itssecond expanded axial length is substantially the same as a width of thetubular mesh along its first expanded axial length, wherein the thirdtubular shaft extends distally through the proximal end opening as wellas the second axial expanded length of the shape memory tubular body.22. A clot capture system, comprising: a first, outer tubular shaftcomprising a central lumen; a second tubular shaft configured to bepositioned within the central lumen of the first, outer tubular shaft,the second tubular shaft comprising a proximal portion and a distalportion, the distal portion more radially expandable than the proximalportion; a third tubular shaft configured to be positioned within acentral lumen of the second tubular shaft; a shape memory tubular bodycomprising a first end, a second end, and an axial length therebetween,the first end having a proximal-facing opening and a ring-shaped captureguide attached to a circumference of the proximal-facing opening, thecapture guide operably attached to the second tubular shaft via a sleevecircumscribing a portion of the second tubular shaft, the second endattached to an outer wall of the third tubular shaft, wherein the shapememory tubular body is compressed within the central lumen of the secondtubular shaft in a delivery configuration, wherein the shape memorytubular body is transformable to a second configuration by axialmovement of the second tubular shaft with respect to the first tubularshaft, in which the first end and the capture guide is radially expandedbut the second end and a segment of the shape memory tubular bodyremains radially compressed within the central lumen of the secondtubular shaft and the second end is positioned proximal to the first endand the shape memory tubular mesh body has a first expanded axiallength, wherein the shape memory tubular body is transformable to athird configuration by movement of the second tubular shaft with respectto the third tubular shaft, in which the shape memory tubular body has asecond expanded axial length greater than the first expanded axiallength, wherein a width of the shape memory tubular shaft along itssecond expanded axial length is substantially the same as a width of theshape memory tubular shaft along its first expanded axial length,wherein the third tubular shaft extends distally through the proximalend opening as well as the second axial expanded length of the shapememory tubular body.
 23. The clot capture system of claim 22, whereinthe shape memory tubular body is transformable to a fourth configurationby movement of the second tubular shaft with respect to the thirdtubular shaft, wherein the shape memory tubular body has a thirdexpanded axial length greater than the second expanded axial length,wherein a width of the shape memory tubular shaft along its thirdexpanded axial length is less than the width of the shape memory tubularshaft along its second expanded axial length.
 24. The clot capturesystem of claim 22, wherein the sleeve comprises a metal or polymer. 25.The clot capture system of claim 22, wherein the sleeve is at leastpartially radiotranslucent under fluoroscopy.